ELLAONE*1FC TAB 30MG

ellaOne 30 mg film-coated tablet
Ulipristal acetate

What it is and what it is used for
ellaOne is an emergency contraceptive
ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or contraceptive failure. For example:
- if you have had unprotected sex;
- if your or your partner's condom broke, slipped off, came off, or if you forgot to use it;
- if you did not take your contraceptive pill as instructed.
You must take the tablet as soon as possible after sex, and in any case no later than 5 days (120 hours). This is because it is more effective the sooner it is taken after unprotected sex.
This medicine is suitable for any woman of childbearing age, including adolescents.
The tablet can be taken at any time of the menstrual cycle.

ellaOne does not work if pregnancy has already occurred.
If your period is late, there is a possibility of pregnancy. If your period is late or if you have symptoms of pregnancy (heavy breasts, morning sickness), you should consult a doctor or healthcare professional before taking the tablet. If you have unprotected sex after taking the tablet, the medicine will not prevent pregnancy. Unprotected sex at any time of the cycle can result in pregnancy.

ellaOne should not be used as a regular contraceptive
If you are not using a regular contraceptive method, speak to a doctor or healthcare professional to choose one that is suitable for you.

How ellaOne works
ellaOne contains the substance ulipristal acetate, which works by modifying the activity of the natural hormone progesterone, which is necessary for ovulation to occur. As a result, this medicine works by delaying ovulation. Emergency contraception is not effective in all cases. For every 100 women who take this medicine, approximately 2 pregnancies occur.

This medicine is a contraceptive used to prevent pregnancy. If you are already pregnant, ellaOne will not terminate an existing pregnancy.

Emergency contraception does not protect against sexually transmitted infections.
Only condom use provides protection against sexually transmitted infections. This medicine does not offer protection against HIV infection or other sexually transmitted diseases (e.g., Chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis). If you are concerned about this, contact a healthcare professional.
Further information on contraception can be found at the end of this leaflet.

What you need to know before taking the medicine
Do not take ellaOne
- if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Speak to your pharmacist, doctor or other healthcare professional before taking this medicine:
- if your period is late or if you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant (see section Pregnancy, breastfeeding and fertility);
- if you suffer from severe asthma;
- if you suffer from severe liver disease.
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse.
Some data suggest that this medicine may be less effective with increasing body weight or body mass index (BMI), but this data is limited and inconclusive. Therefore, ellaOne is recommended for all women regardless of weight or BMI.
If you are concerned about problems related to taking emergency contraception, speak to a healthcare professional.
If you become pregnant despite taking the tablet, it is important that you see a doctor. See the section Pregnancy, breastfeeding and fertility for more information.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms, such as breast pain and abdominal pain (stomach ache), vomiting and discomfort (nausea) are also possible signs of pregnancy. If you miss a period and experience these symptoms after taking ellaOne, you should perform a pregnancy test (see section Pregnancy, breastfeeding and fertility).

Common side effects (may affect up to 1 in 10 people)
- nausea, abdominal pain (stomach ache) or discomfort, vomiting
- painful periods, pelvic pain, breast pain
- headache, dizziness, mood swings
- muscle aches, back pain, fatigue

Uncommon side effects (may affect up to 1 in 100 people)
- diarrhoea, heartburn, flatulence (intestinal gas), dry mouth
- unusual or irregular vaginal bleeding, heavy/prolonged periods, premenstrual syndrome, vaginal irritation or discharge, decreased or increased libido (sexual desire)
- hot flashes
- changes in appetite, emotional disturbances, anxiety, agitation, difficulty falling asleep, somnolence, migraine, visual disturbances
- flu
- acne, skin lesions, itching
- fever, chills, malaise

Rare side effects (may affect up to 1 in 1,000 people)
- genital pain or itching, pain during sexual intercourse, rupture of ovarian cyst, unusually light periods
- loss of concentration, dizziness, tremors, disorientation, fainting
- abnormal sensation in the eyes, redness of the eyes, sensitivity to light
- dry throat, taste disorders
- allergic reactions such as rash, hives or facial swelling
- feeling thirsty

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.